The design of case report forms (CRFs) in multicenter trials should capture what?

• A. Only data for the core investigators.
• B. The required data at all sites; supplemental CRFs may capture additional data.
• C. Data only on adverse events.
• D. Data only for primary endpoints.

Answer: (B)

In multicenter trials, the CRFs must gather the data required by the protocol at every site. This ensures all essential information—safety events, endpoints, demographics, baseline measures, and concomitant medications—exists in a uniform, verifiable form across the whole study. Supplemental CRFs can be used to capture additional data that isn’t essential for the primary analyses but may support exploratory or site-specific questions. Limiting data collection to only adverse events or only primary endpoints would leave important information out and could undermine data integrity and regulatory review.